Certificate No. 60136204

Certificate Number: 60136204
Certificate Holder: Bösl Medizintechnik GmbH

Charlottenburger Allee 13
52068 Aachen
Germany
Scope:

Medical devices for sequential, intermittent
compression therapy
Replaces Approval, Registration No.: HD 60111406 0001

Fulfilled Standards: Richtlinie 93/42/EWG
Certificate Type: Vollst. QMS, Anhang II MDD

EC declaration of conformity (Full quality assurance system)
Certificate according to Annex II Section 3 of the EC Directive 93/42/EEC concerning Medical Devices

The Notified Body hereby certifies the application of the quality system by the manufacturer approved for the design, manufacture and final inspection of the products concerned, as specified in Annex II, Section 3 of the EC directive 93/42/EEC.

The manufacturer is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

This approval can be used by the company in line with the declaration of conformity.